North America

HoneyNaps gains FDA clearance for AI sleep-disordered breathing software

SOMNUM V3.0 supports automated analysis of polysomnography data and classifies obstructive, central and mixed sleep apnea events....

Spark Biomedical study supports non-invasive neurostimulation for bleeding control

The first-in-human study showed that wearable auricular neurostimulation enhanced platelet function without systemic effects or adverse events....

Xenter raises $58.25M to expand wireless medical device platform

The funding will support commercial launch of XenFi and planned clinical testing of the Guru dual-sensor physiology guidewire in TAVR procedures....

BIOTRONIK Neuro acquires spinal cord stimulation IP from Soin Neuroscience

The acquisition adds patents covering waveform design, adaptive programming and AI-enabled neuromodulation to BIOTRONIK Neuro’s chronic pain platform....

TytoCare raises $25M to scale AI-enabled remote examination platform

The company is expanding its FDA-cleared remote examination and SaMD platform for cardiopulmonary, oncology and chronic disease care....

Tempus Highlights AI's Role in Improving Prostate Biopsy Reporting Accuracy

Findings from the multi-center Articulate Pro study show Paige Prostate improves diagnostic consistency, accelerates turnaround times, and reduces laboratory workloads...

Medusind Appoints Raju Siva as Chief AI Officer to Advance AI Strategy and Intelligent Automation

The appointment marks an important milestone in Medusind’s continued investment in AI-powered solutions that help healthcare providers increase operational efficiency...

CareDx Announces Finalization of Solid Organ Transplant Molecular Testing Local Coverage Determination

The final policy affirms coverage across CareDx’s transplant surveillance offerings in kidney, heart, and lung...

Autonomous Healthcare receives FDA De Novo authorization for ventilator waveform software

Syncron-E detects evidence of ineffective patient efforts in ventilated adults, creating a new FDA device category for ventilator waveform analysis software....

ElectroWire Medical gains FDA clearance for transseptal puncture system

The LightningWire system is designed to support transseptal access in procedures such as atrial fibrillation ablation, left atrial appendage closure and transcatheter mitral interventions....